Cleared Traditional

KOMET SURGICAL BUR (K883255) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K883255 · Komet Medical, Div. of Brasseler USA I, L.P. · General & Plastic Surgery device
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Sep 1988
Decision
44d
Days
Class 1
Risk

K883255 is an FDA 510(k) clearance for the KOMET SURGICAL BUR. Classified as Bur, Surgical, General & Plastic Surgery (product code GFF), Class I - General Controls.

Submitted by Komet Medical, Div. of Brasseler USA I, L.P. (Savannah, US). The FDA issued a Cleared decision on September 15, 1988 after a review of 44 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4820 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Komet Medical, Div. of Brasseler USA I, L.P. devices

Submission Details

510(k) Number K883255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1988
Decision Date September 15, 1988
Days to Decision 44 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 115d · This submission: 44d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GFF Bur, Surgical, General & Plastic Surgery
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.